1. Field of the Invention
This invention relates generally to hemostatic products, and particularly to the surprisingly improved performance of a novel hemostatic device which includes potassium ferrate and a cationic exchange resin when applied to a bleeding or exudating wound.
2. Description of Related Art
Hemostasis powders are well known. Thompson et al, U.S. Pat. No. 4,545,974 & U.S. Pat. No. 4,551,326, disclose processes for the manufacture of potassium ferrate and similar high oxidation state oxyiron compounds. Patterson et al U.S. Pat. No. 6,187,347 and Patterson et al. U.S. Pat. No. 6,521,265, disclose the mixing of potassium ferrate and anhydrous strongly acidic cation exchange resins for the cessation of bleeding. These patents are incorporated by reference herein in their entirety. Kuo et al. (J. Vasc Interv. Radial. 19:1 7279 2008) disclose the benefit of ferrate/resin mixtures in reducing the time to hemostasis (TTH) from 6 minutes to 4 minutes versus D-stat, the market leader in hemostasis pads. Michelson (The American Journal of Cosmetic Surgery 25-3 2008) shows that the ferrate/resin mixtures are excellent for wound care. Michelson demonstrated complete closure of a patient with twin brachial dehisced wounds following cosmetic surgery. After 16 weeks, the patient healed without scarring.
Cook et al. in U.S. Pat. No. 2,923,664 disclose a hemostatic tablet formed by the wet granulation and compression of a mixture of cellulose glycolic acid ether and its sodium salt. Kuntz et al. in U.S. Pat. No. 3,368,911 disclose a hemostatic sponge prepared by freeze drying acid swollen collagen fibrils. Pawelchak et al. in U.S. Pat. No. 4,292,972 disclose a lyophilized hydrocolloid foam possessing hemostatic properties. The prior art illustrates the hemostatic tablet or sponge but provide little comparison with the powder or granulation from which the tablet originates from.
There is an unmet need for providing an alternate means for delivering a hemostatic dressing onto a wound which avoids the mess associated with the handling, application and delivery of a loose, granular powder to the wound site. A solid device, preferably a tablet, formed from loose hemostatic powder is very dense due to the high compressive force to prepare the tablet. A loose powder compressed into a solid intuitively creates a less messy product application, but the compression process results in a reduction in surface area. Therefore, the free loose hemostatic powder would be expected to be faster acting compared to the solid tablet form of this material. The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art upon a reading of the specification and a study of the drawings.